Generics firms wary of EC anti-counterfeit proposals

European Commission proposals aimed at combating the trade in counterfeit medicines will damage the generics industry without achieving their desired objectives, according to the organisation representing European generic drugmakers.

Greg Perry, director general of the European Generic Medicines Association (EGA), told delegates at the group’s annual meeting in Barcelona, Spain, that a blanket introduction of serialisation of medicines and the use of tamper-evident seals adds significant costs to the manufacturing of medicines “and will not stop counterfeit medicines from reaching patients,” according to an APM Health report.

A spokesperson for the EGA said the group believes that “technical solutions serve
other purposes related to reimbursement fraud or recall systems, for instance, but will not add value to the fight against counterfeiting.”

In fact, over-reliance on technology could also provide a false sense of security, she added, citing an EGA position paper published earlier this year.

Generic medicines are rarely counterfeited, Perry told the meeting, because counterfeiters tend to focus on higher-priced originator brands. The low price of generic medicines means there is no margin for counterfeiters, he argued.

The EC proposals include provision for a risk-based approach for traceability requirements, based on the likelihood of being counterfeited which is in turn predicated on price and past incidents of counterfeiting.

This has been welcomed by the EGA as it believes that, because generics are seldom targeted by counterfeiters, they should be excluded from such measures.

Adding features such as serialisation and tamper-evident seals could add as much as €20 billion to the industry’s costs, Perry told the meeting, and this will reduce the ability of the generic medicines industry to provide affordable medicines
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Instead of relying on these technology-based approaches to anti-counterfeiting, he believes other measures, such as improved enforcement activities and stiffer penalties for counterfeiters would have a greater impact.

The creation of a European inspectorate and harmonisation of wholesale and import licensing would go a long way to tackling the problem.